FDA.reportPublic FDA data

Application 021001

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AXERTALMOTRIPTAN MALATETABLET;ORALEQ 6.25MG BASEYesNo
002AXERTALMOTRIPTAN MALATETABLET;ORALEQ 12.5MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-210AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent
50458-210AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent
50458-210AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent
50458-211AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent
50458-211AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent
50458-211AXERTalmotriptan malateJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48399SUPPL2017-05-17
48385SUPPL2017-05-17
4005SUPPL2014-08-11
35850SUPPL2014-08-08
35849SUPPL2009-05-11
14139SUPPL2009-05-11
4004SUPPL2009-05-06
35848SUPPL2009-04-03
14138SUPPL2009-04-03
26451SUPPL2009-04-01
4003SUPPL2009-04-01
51214SUPPL2005-02-01
26450SUPPL2004-06-07
41869ORIG2004-04-15
23617ORIG2003-12-08
51213SUPPL2001-10-05
26449ORIG2001-05-07
14137ORIG2001-05-07
63849ORIG1900-01-01
63848ORIG1900-01-01
58101ORIG1900-01-01
53170ORIG1900-01-01
53169ORIG1900-01-01